Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. July 12, 2021 Medtronic, Inc. Alexandra Theisen Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112 #### Re: K203556 Trade/Device Name: Medtronic Model 5492A. 5492V. 5492AL. 5492VL Patient Cables Regulation Number: 21 CFR 870.2900 Regulation Name: Patient Transducer and Electrode Cable (Including Connector) Regulatory Class: Class II Product Code: DSA Dated: June 14, 2021 Received: June 15, 2021 #### Dear Alexandra Theisen: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Hetal Odobasic Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K203556 Device Name Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables Indications for Use (Describe) The Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments. The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with: · Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long. · Medtronic cardiovascular stimulating instruments. | Type of Use (Select one or both, as applicable) | <table><tr><td><input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 601 Subpart D) </td></tr><tr><td><input type="checkbox"/> Same Therapeutic Context Use (21 CFR 601 Subpart C) </td></tr></table> | <input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 601 Subpart D) | <input type="checkbox"/> Same Therapeutic Context Use (21 CFR 601 Subpart C) | |----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <input checked="checked" type="checkbox"/> Remediation Use (Part 21 CFR 601 Subpart D) | | | | | <input type="checkbox"/> Same Therapeutic Context Use (21 CFR 601 Subpart C) | | | | |X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Page 1 of {3}------------------------------------------------ # 510(k) Summary [As required by 21 CFR 807.92] Date Prepared: December 04, 2020 | General Information | | | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables | | | Common Name | Patient cable | | | Product Code | DSA | | | Classification | II | | | Regulation Number | 21 CFR 870.2900 | | | Panel | Cardiovascular | | | Predicate Device | Medtronic Model 5487/5487L Disposable Patient Cables K960446 | | | Submitter | Medtronic, Inc.<br>Cardiac Rhythm Management<br>8200 Coral Sea Street<br>Mounds View, MN 55112 | | | Contact Person | Primary Contact<br>Alexandra Theisen<br>Senior Regulatory Affairs Specialist<br>alexandra.r.theisen@medtronic.com<br>Tel: 763.526.6758 (direct)<br>Fax: 651.367.0603 | Alternate Contact<br>Wendy Saunders<br>Regulatory Affairs Director<br>wendy.a.saunders@medtronic.com<br>Tel: 763.526.8134 (direct)<br>Fax: 651.367.0603 | # Brief Device Description The 5492 A-V Patient Cables are reusable patient cables that are designed to connect a temporary pacemaker to atrial and ventricular pacing lead systems. # Indications for Use The Medtronic Model 5492A, 5492V, 5492AL, 5492VL patient cables are intended for use as part of a temporary cardiac pacing system. They connect atrial and ventricular pacing lead systems to a temporary external pacemaker. They are intended for use by trained clinicians in a clinical environment. For more information about the intended use of and the indications for temporary cardiac pacing systems, refer to the technical manuals for the cardiovascular stimulating instruments. The Model 5492A, 5492V, 5492AL, 5492VL reusable patient cables are intended to be used with: - . Medtronic endocardial or myocardial pacing lead connector pins 0.38 to 2.41 mm (0.015 to 0.095 in.) in diameter and up to 25.4 mm (1.0 in.) long. - Medtronic cardiovascular stimulating instruments. ● {4}------------------------------------------------ # Technological Characteristics Intended use, design, performance and technological characteristics are substantially equivalent to the predicate devices referenced. When compared to the predicate device (K960446), the 5492 A-V Patient Cables presented in this submission have similar: - o Intended use/indications for use - Operating principle ● - Design features ● - Device functionality . The 5492 A-V Patient Cables and the predicate device differ in the following: - Usage (i.e. reusable versus disposable) ● - Sterility (i.e. supplied non-sterile versus supplied sterile) ● ### Substantial Equivalence and Summary of Studies: Technological differences between the subject and predicate devices have been evaluated through bench tests. The following test data provided in this Traditional 510(k) submission has been completed: - Sterilization (reference Sterilization) - Biocompatibility (reference Biocompatibility) ● - o Electrical Safety (reference EMC and Electrical Safety) - o Performance Testing (reference Performance Testing - Bench) # Conclusion Medtronic has demonstrated that the 5492 A-V Patient Cables described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are substantially equivalent from the predicate device.